Information de reference pour ce titreAccession Number: | 00080647-200801070-00001.
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Author: | Elder, D. P. a,1; Teasdale, A. b,1; Lipczynski, A. M. c,1,*
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Institution: | (a)GlaxoSmithKline R&D, Park Road, Ware SG12 0DP, UK (b)AstraZeneca R&D, Charnwood, Bakewell Road, Loughborough LE11 5RH, UK (c)Pfizer Global R&D, Sandwich, Kent CT13 9NJ, UK
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Title: | |
Source: | Journal of Pharmaceutical and Biomedical Analysis. 46(1):1-8, January 2008.
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Abstract: | This article reviews current regulatory guidelines and relevant scientific literature pertaining to the control and analysis of potential genotoxic impurities (PGIs) in new active pharmaceutical ingredients (APIs) with specific reference to a certain sub-class of PGIs, namely alkyl esters of alkyl and aryl sulfonic acids. Sulfonic acids are very important in pharmaceutical R&D employed both as counter-ions in the formation of acid-addition salts and also as reagents and catalysts in the synthesis of new drug substances. The article reviews the evolution of analytical methodology from early studies in the mid 1970s through development of direct injection GC and HPLC methods to liquid-liquid/solid phase extraction and headspace based techniques coupled to HPLC and GC methodologies employing UV and MS detection to new derivatisation-based techniques.
The paper also reflects on the significant challenges in developing robust analytical methodology capable of the trace determination of sulfonate esters, the challenges in transferring methodology from R&D to QC labs and on the cost of inappropriate limits for genotox impurities. In so doing, the authors seek to inform the debate that the control of genotoxic impurities should be driven primarily by safety and risk/benefit considerations rather than by state-of-the-art analytical and process chemistry capabilities that drive controls to levels 'as low as practicable' regardless of the risk/safety requirements.
(C) 2008Elsevier, Inc.
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Author Keywords: | Sulfonate esters; Analysis; Regulatory guidelines.
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References: | [1] Council of Europe. 2000. Enquiry: alkyl mesilate (methanesulphonate) impurities in mesilate salts. Pharmeuropa. 12, 27.
[2] European Pharmacopoeia, Dihydroergocristine Mesilate monograph, Ph. Eur. 5.0 (2005) 1437-1439.
[3] ICH Q9, Quality Risk Management, June 2006, http://www.ICH.org/- ouverture dans une nouvelle fenêtre.
[4] ICH Q8, Pharmaceutical Development, May 2006, http://www.ICH.org/- ouverture dans une nouvelle fenêtre.
[5] United States Pharmacopeia, Atracurium Besylate monograph, USP 29 (2006) 216-217.
[6] Guideline on the Limits of Genotoxic Impurities, Committee for Medicinal Products (CHMP), European Medicines Agency, London, 28 June 2006. (CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006).
[7] ICH Q3A (R), Impurities in New Drug Substances, February 2002, http://www.ICH.org/- ouverture dans une nouvelle fenêtre.
[8] ICH Q3B (R2), Impurities in New Drug Products, July 2006, http://www.ICH.org/- ouverture dans une nouvelle fenêtre.
[9] R. Kroes, A.G. Renwick, M. Cheeseman, J. Kleiner, I. Mangelsdorf, A. Piersma, B. Schilter, J. Sclatter, F. van Schothorst, J.G. Vos, G. Wurtzen, Food Chem. Toxicol. 42 (2004) 65-83.
[10] L. Muller, R.J. Mauthe, C.M. Riley, M.M. Andino, D. de Antonis, C. Beels, J. DeGeorge, A.G.M. De Knaep, D. Ellison, J.A. Fagerland, R. Frank, B. Fritschel, S. Galloway, E. Harpur, C.D.N. Humfrey, A.S. Jacks, N. Jagota, J. Mackinnon, G. Mohan, D.K. Ness, M.R. O'Donovan, M.D. Smith, G. Vudathala, L. Yotti, Reg. Toxicol. Pharm. 44 (2006) 198-211.
[11] ICH Q3C, Impurities: Guidelines for Residual Solvents, July 1997, http://www.ICH.org/- ouverture dans une nouvelle fenêtre.
[12] K.L. Dobo, N. Greene, M.O. Cyr, S. Caron, W.W. Ku, Reg. Toxicol. Pharm. 44 (2006) 282-293.
[13] S.A. Miller, J. Ju, M. Cucolo, J.Y. Dai, J. Jia, K. Narra, A.M. Smith, A.-F. Aubrey, Poster at the 52nd ASMS Conference, 2004.
[14] D.J. Snoddin, Reg. Toxicol. Pharm. 45 (2006) 79-90.
[15] W.G. Filby, K. Gunther, R.-D. Penzhorn, Anal. Chem. 47 (1975) 2283-2285.
[16] H.G. Ramjit, M.M. Singh, A.B. Coddington, J. Mass Spectrom. 31 (1996) 867-872.
[17] W. Li, J. Chromatogr. A. 1046 (2004) 297-301.
[18] I. Colon, S.M. Richoll, J. Pharm. Biomed. Anal. 39 (2005) 477-485.
[19] G.E. Taylor, M. Gosling, A. Pearce, J. Chromatgr. A. 1119 (2006) 231-237.
[20] C.R. Lee, F. Guivarch, C.N. Van Dau, D. Tessier, A.M. Krstulovic, Analyst. 128 (2003) 857-863.
[21] R. Alzaga, R.W. Ryan, K. Taylor-Worth, A.M. Lipczynski, R. Szucs, P. Sandra, J. Pharm. Biomed Anal. 45 (2007) 472-479.
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Language: | English.
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Document Type: | Review.
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Journal Subset: | Pharmacology.
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ISSN: | 0731-7085
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DOI Number: | https://dx.doi.org/10.1016/j.jpb...- ouverture dans une nouvelle fenêtre
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